Nov. 3, 2015 – Roche and Ariosa Diagnostics, a global leader in non-invasive prenatal testing technology and maker of the Harmony™ Prenatal Test, today announced the results of a new clinical study on the company’s targeted cell-free DNA analysis using microarray quantitation which...

Oct. 13, 2015 - Roche and Ariosa Diagnostics, in conjunction with Australian company Sonic Healthcare, today announced that Sonic Healthcare has been granted a license to perform the Harmony Prenatal Test in its Australian and United Kingdom labs.

*The Harmony Prenatal Test is developed by Ariosa Diagnostics. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies.Non-invasive prenatal testing (NIPT) services based on cell-free DNA analyses are not diagnostic; results should be confirmed by diagnostic testing.Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.